ENCePP Guide on Methodological Standards in Pharmacoepidemiology

9.2. Scientific integrity and ethical conduct

Principles of scientific
integrity and ethical conduct are paramount in any medical research. The Declaration of Helsinki provides ethical principles addressed primarily to physicians
involved in medical researchinvolving human subjects, including research on
identifiable human material and data.The ENCePP
Code of Conduct offers standardsfor scientific independence and transparency of
research in pharmacoepidemiology and pharmacovigilance. To this end, the
Code of conduct promotes best practice for the interactions between
investigators and study funders in critical areas such as planning, conduct and
reporting of studies. As a core transparency measure, it recommends that the
protocols of all pharmacoepidemiology and pharmacovigilance studies should be
registered in the EU PAS
Register, ideally before they start, and study findings published
irrespective of positive or negative results, to avoid publication bias.

Guided
bythree core values (best science, strengthening public health,
transparency), the ADVANCE Code of Conduct for Collaborative Vaccine
Studies (Vaccine 2017;35(15):1844-55) includes 45 recommendations across 10 topics (Scientificintegrity, Scientific independence, Transparency, Conflicts
of interest, Study protocol, Study report,Publication, Subject privacy, Sharing of study data,
Research contract). Each topic includes a definition,a set of recommendations and a list of additional reading.
The concept of the study team is introducedas
a key component of the ADVANCE Code of Conduct with a core set of roles and
responsibilities. It also provides direct access to a comprehensive list
of relevant guidelines. The Good Pharmacoepidemiology Practices (GPP) of the International Society for Pharmacoepidemiology
(ISPE) proposes practices and proceduresthat
should be considered to help ensure the quality and integrity of
pharmacoepidemiological research, including detailed guidance for protocol
development, roles and responsibilities, study conduct, communication, reporting
of adverse events and archiving. The Good
Epidemiology Practice (GEP) of the
International Epidemiological Association addresses four general ethical
principles for research (Autonomy, Beneficence, Non-maleficence and Justice) and
proposes rules for good research behaviour in relation to working with personal
data, data documentation, publication, the exercise of judgment and scientific misconduct.

The CIOMS International Ethical Guidelines for Health-related Research
Involving Humans (Geneva: 2016) provides international vetted ethical
principles and detailed commentary on how universal ethical principles should be
applied, with particular attention to conducting research in low-resource
settings. It includes 25 guidelines addressing different topics, settings and
population groups concerned by health-related research.